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Does Using a Low Vision Aid Device Improve Quality of Life in Glaucoma Patients?

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ClinicalTrials.gov Identifier: NCT02526680
Recruitment Status : Completed
First Posted : August 18, 2015
Results First Posted : November 21, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
L. Jay Katz MD, Wills Eye

Tracking Information
First Submitted Date  ICMJE August 6, 2015
First Posted Date  ICMJE August 18, 2015
Results First Submitted Date  ICMJE December 21, 2017
Results First Posted Date  ICMJE November 21, 2018
Last Update Posted Date December 13, 2018
Study Start Date  ICMJE May 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
Impact of OrCam on Vision-related Quality of Life [ Time Frame: 1 month ]
National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) is a series of questions pertaining to vision or feelings about a vision condition in relation to functional status to assess their quality of life. Multiple choice responses from 12 subscales (general vision, near vision, distance vision, ocular pain, social functioning, mental health, roll difficulties, dependency, driving, color vision and peripheral vision) were recorded into a 0-100 score where 0 represents the lowest perceived vision difficulties and 100 the highest perceived difficulties. NEI-VFQ-25 was used to measure the number of participants who showed improvement in vision-related quality of life after using the OrCam device over a one month period.
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
NEI-VFQ-25 [ Time Frame: 1 month ]
Change History Complete list of historical versions of study NCT02526680 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2018)
  • Impact of OrCam on Reading Newspapers [ Time Frame: 1 month ]
    Participants were asked 'Did OrCam increase your quality of life in reading newspapers?' after a one month trial period with the device. Number of subjects answering Yes is provided.
  • Impact of OrCam on Grocery Shopping [ Time Frame: 1 month ]
    Participants were asked 'Did OrCam improve your quality of life while grocery shopping?' after a one month trial period with the device. Number of subjects answering Yes is provided.
  • Recommending OrCam to Others [ Time Frame: 1 month ]
    Participants were asked 'How likely would you be to recommend OrCam to another visually impaired person?' after a one month trial period with the device. Number of subjects answering Very Likely or Likely is provided.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
Timed reading of an article [ Time Frame: 1 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Using a Low Vision Aid Device Improve Quality of Life in Glaucoma Patients?
Official Title  ICMJE The Impact of a Novel Artificial Vision Device (OrCam) on the Quality of Life of Patients With Advanced Glaucoma
Brief Summary

To determine the impact of OrCam over 1 month on health-related quality of life (HRQoL) in subjects with advanced glaucoma using the National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ-25).

To identify tasks for which subjects are using the OrCam device and patient satisfaction.

Detailed Description

Participants will document their daily impression about the use of OrCam, a small camera attached to their glasses over a 1-month period. They will attend 2 appointments at Wills Eye Hospital Glaucoma Research Center (baseline and final visit). Participant's will be trained to use the OrCam device at baseline visit and complete a best-corrected visual acuity assessment ETDRS (early treatment diabetic retinopathy study) and the NEI-VFQ-25 questionnaire. They will also read a short newspaper article.

The NEI-VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score will be calculated by averaging vision-targeted subscale scores, excluding the general health rating question.

Participants will read a short article. They will be asked to grade their reading difficulty between 1 (unable to read) to 10 (able to read without difficulty). Time to read article will be recorded. Reading task will be performed with best correction - with and without the assistance of the OrCam device.

Subjects will utilize OrCam daily for one month. Each week, subjects will record thoughts about the device in a log book or by using audio tape recorder, according to patient's personal preference.

Final assessment at 1 month will include best-corrected visual acuity (ETDRS), NEI-VFQ-25, and the newspaper-reading task with and without OrCam assistance. A satisfaction questionnaire will be completed in order to assess subjects' overall feelings regarding OrCam. Audio log books will be analyzed for specific factors and recorded by a research assistant.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Glaucoma
Intervention  ICMJE Device: OrCam
The OrCam low vision aid, camera attached to glasses, used by 27 glaucoma subjects for 1 month.
Study Arms  ICMJE Experimental: Glaucoma Subjects
27 glaucoma subjects will be given the OrCam low vision aid device to use for 1 month.
Intervention: Device: OrCam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2018)
27
Original Actual Enrollment  ICMJE
 (submitted: August 14, 2015)
13
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Glaucoma any type, characterized by glaucomatous optic neuropathy and corresponding visual field (VF) defect
  • Visual acuity of 20/400 to hand motion (HM) in better eye or visual field less than 10 degrees in better eye and having difficulty reading.
  • Age 18 years or older
  • Able to understand and speak English
  • Able to use an electronic recording device
  • Able to operate a computerized system

Exclusion Criteria:

  • Neurological or musculoskeletal problems that would influence performance on activities of daily living
  • Incisional eye surgery within past three months
  • Laser therapy within previous month
  • Any cause for visual impairment other than glaucoma
  • Photophobia
  • Any medical condition precluding subject from providing reliable, valid data
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02526680
Other Study ID Numbers  ICMJE 14-396
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Manuscript accepted for publication August 2018.
Responsible Party L. Jay Katz MD, Wills Eye
Study Sponsor  ICMJE Wills Eye
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: L. Jay Katz, MD Wills Eye Hospital
PRS Account Wills Eye
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP